Bexepril 2.5 mg Film-coated tablet for dogs

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Benazepril hydrochloride

可用日期:

Chanelle Pharmaceuticals Manufacturing Limited

ATC代码:

QC09AA07

INN（国际名称）:

Benazepril hydrochloride

剂量:

2.5 mg/tablet

药物剂型:

Film-coated tablet

处方类型:

POM: Prescription Only Medicine as defined in relevant national legislation

治疗组:

Dogs

治疗领域:

benazepril

疗效迹象:

Cardiovascular

授权状态:

Authorised

授权日期:

2010-06-04

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bexepril 2.5 mg Film-coated tablet for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each tablet contains:
Benazepril
2.3 mg
(equivalent to Benazepril Hydrochloride 2.5 mg)
EXCIPIENT:
Titanium Dioxide (E171)
0.5 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
A white round biconvex tablet with break line on one side. The tablets
can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In dogs weighing more than 5 kg:
Treatment of congestive heart failure associated with, in particular,
dilated cardiomyopathy and/or mitral insufficiency.
4.3 CONTRAINDICATIONS
Do not use in any dog that has evidence of cardiac output failure due,
for example, to aortic stenosis.
Do not use in animals known to be hypersensitive to the active
substance or to any of the excipient(s).
See Section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
No evidence of renal toxicity to the product has been observed in dogs
during clinical trials. However, as is routine in
cases of renal insufficiency, it is recommended to monitor